Micro-aseptic 81591-001

Micro-aseptic 81591-001
SPL v2
SPL
SPL Set ID bc40ac4f-6c0e-82fd-e053-2995a90a5db3
Route
TOPICAL
Published
Effective Date 2021-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (0.6 g)
Inactive Ingredients
Water Fd&c Blue No. 1 Aloe Vera Leaf Fd&c Yellow No. 5 Sodium Lauryl Sulfate Cocamidopropyl Betaine Propylene Glycol Isopropyl Alcohol Dmdm Hydantoin Peg-75 Lanolin Lauramine Oxide Sodium Laureth Sulfate Edetate Sodium Boric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-26

Description

PCMX (para-chloro-meta-xylenol) 0.6%

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

PCMX (para-chloro-meta-xylenol) 0.6%

Use

for hand-washing to decrease bacteria on the skin

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control center right away

Section 50566-9

Stop use and ask a doctor if

  • irritation and redness develop
Section 50567-7

When using this product

  • do not get into eyes
  • of contact occurs, rinse eyes thoroughly with water

Section 51945-4

Micro-

Aseptic

Antimicrobial

Skin Cleanser

NDC # 81591-001-02

Manufactured for

ASEPTIC CONTROL PRODUCTS, INC

1225 Carnegie Street, Unit 104

Rolling Meadows, IL 60008

Made in the U.S.A.

Item #: 1955-16OZ

473 ml (16 FL. OZ.)

Warnings

For external use only

Directions
  • ready to use
  • do not dilute
  • wet hands and forearms
  • apply 5 milliters (teaspoonful) or palmful to hands and forearms
  • scrub thoroughly for 1 minute and rinse
Active Ingredient

PCMX (para-chloro-meta-xylenol) 0.6%

Inactive Ingredients

Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropylbetaine, Propylene Glycol, Tetrasodium EDTA, Isopropanol, Lauramine oxide, Boric Acid, PEG-75 Lanolin, DMDM Hydantoin, Fragrance, Aloe Vera, FD&C Blue #1, FD&C Yellow #5


Structured Label Content

Use

for hand-washing to decrease bacteria on the skin

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • irritation and redness develop
Section 50567-7 (50567-7)

When using this product

  • do not get into eyes
  • of contact occurs, rinse eyes thoroughly with water

Section 51945-4 (51945-4)

Micro-

Aseptic

Antimicrobial

Skin Cleanser

NDC # 81591-001-02

Manufactured for

ASEPTIC CONTROL PRODUCTS, INC

1225 Carnegie Street, Unit 104

Rolling Meadows, IL 60008

Made in the U.S.A.

Item #: 1955-16OZ

473 ml (16 FL. OZ.)

Purpose

Antimicrobial

Warnings

For external use only

Directions
  • ready to use
  • do not dilute
  • wet hands and forearms
  • apply 5 milliters (teaspoonful) or palmful to hands and forearms
  • scrub thoroughly for 1 minute and rinse
Active Ingredient

PCMX (para-chloro-meta-xylenol) 0.6%

Inactive Ingredients

Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropylbetaine, Propylene Glycol, Tetrasodium EDTA, Isopropanol, Lauramine oxide, Boric Acid, PEG-75 Lanolin, DMDM Hydantoin, Fragrance, Aloe Vera, FD&C Blue #1, FD&C Yellow #5


Advanced Ingredient Data


Raw Label Data

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